lexiara

1.

In order to obtain the inclusion in Annex I, II, or III of a new pharmacologically active substance which is: intended for use in veterinary medicinal products for administration to food-producing animals, and intended to be placed on the market of one or more Member States which have not previously authorized the use of the substance concerned in food-producing animals, the person responsible for marketing shall submit an application to the Commission. The application shall contain the information and particulars referred to in Annex V and shall comply with the principles laid down in Directive 81/852/EEC.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.